Kornimate/medical-research-clean huggingface dataset:
paclitaxel in treating patients with early-stage bladder cancer

Conditions: Bladder Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i/ii trial to study the effectiveness of paclitaxel in treating patients with early-stage bladder cancer.

objectives: i. evaluate toxicity and safety of intravesical paclitaxel in patients with superficial bladder cancer. ii. evaluate the efficacy of paclitaxel against transitional cell carcinoma in situ (cis) and/or unresectable papillary superficial bladder cancer. iii. evaluate a dose-response effect and choose an appropriate dose for further clinical study. outline: cohorts of patients receive intravesical paclitaxel in escalating doses, administered twice weekly for 6 weeks, then once every 2 weeks for another 6 weeks, for a maximum of 2 courses at a dose level. patients must complete 8 of the first 15 instillations and a 3 month cystoscopic exam with biopsy and cytology to be deemed evaluable. participants are followed by quarterly cytoscopy and cytology for an additional 21 month period. biopsies are performed at 3 and/or 6 months, and thereafter if clinically applicable. projected accrual: 19 evaluable patients will be enrolled.

Eligibility criteria:
disease characteristics: histologically proven cis and/or unresectable/residual superficial bladder tumor (pta g1-g3 to pt1 g1-g3) -confirmed by biopsy, bladder mapping, or positive cytology cystoscopic examination and bladder mapping must be performed within 6 weeks of study patient characteristics: age: 18 and over performance status: karnofsky of 60 to 100% life expectancy: not specified hematopoietic: hemoglobin greater than 11 g/dl wbc greater than 4500/mm3 neutrophils greater than 1500/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin, ast, and alt no greater than 2.5 x normal renal: creatinine no greater than 2.5 x normal cardiovascular: no concurrent cardiovascular disease other: no active infection requiring concurrent therapy not pregnant or nursing no upper renal tract disease no concurrent malignancy except for basal or squamous cell skin cancer or noninvasive cancer of the cervix prior concurrent therapy: biologic therapy: no intravesical bcg within 3 months prior to study entry prior bcg therapy is required for cis patients (if not contraindicated) chemotherapy: no prior intravesical chemotherapy within 4 weeks prior to study no prior systemic anticancer therapy within 4 months prior to study no prior paclitaxel therapy endocrine therapy: not specified radiotherapy: no prior radiotherapy within 4 months prior to study surgery: not specified other: no hypersensitivity reactions to products containing cremophor

Keywords: stage 0 bladder cancer stage i bladder cancer transitional cell carcinoma of the bladder
a study of pf-04620110 as a modified-release formulation in healthy overweight or obese subjects

Conditions: Healthy

Summary: the primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of pf-04620110 as a modified-release formulation.

to evaluate the safety and tolerability, pharmacokinetics (pk), and pharmacodynamics, of multiple oral doses of pf-04620110 as a modified-release formulation.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 27 to 35 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Keywords: multiple dose study overweight healthy subjects body weight modified-release formulation
observation of the effects of guideline-driven lifestyle interventions, including use of a red-yeast based nutraceutical

Conditions: Hypercholesterolemia

Summary: the objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical.

the objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical significantly increases the ldl-c lowering effect of guideline-driven lifestyle interventions in subjects with hypercholesterolemia at low-moderate cardiovascular risk not requiring a drug therapy.

Eligibility criteria:
inclusion criteria: * age between 25 and 75 years; * in primary prevention for low-moderate cv risk, with diet and physical exercise to control raised ldl-c level, for at least 3 months; * ldl-c \> 100 mg/dl (2.6 mmol/l), \< 190 mg/dl (4.9 mmol/l) * cv risk score \<5% (based on score chart according to figure i for poland respective figure 2 for austria and germany in the esc/eas guideline 2019); * triglyceride \<400 mg/dl; * advised to use nutraceutical as part of the lifestyle intervention as per guideline and within the product label (i.e. posology as in product label); * written informed consent. exclusion criteria: * subjects being treated or who have been treated for up to 3 months before the start of the study with lipid-lowering drugs or nutraceuticals including functional foods for which lipid-lowering effects are known (e.g. fish oil, sterol-containing yoghurts etc.); * subjects involved in other clinical studies with pharmaceutical products * known laboratory evidence of either liver, muscle, thyroid or kidney dysfunction; * subjects with prior history of cardiovascular events or with high cardiovascular risk equivalents; * uncontrolled hypertension (systolic blood pressure \>190 mmhg or diastolic blood pressure \>100 mmhg); * pregnancy and breastfeeding.
a study of rg7314 to investigate efficacy and safety in individuals with autism spectrum disorders (asd)

Conditions: Autism Spectrum Disorder

Summary: this multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of rg7314 in adult participants with asd. in stage i of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg) rg7314 or placebo for 12 weeks. after an independent safety review, the study may proceed to stage ii. in stage ii of the study, additional participants will be randomized in 2:1 to receive daily oral doses of 4 mg rg7314 or placebo for 12 weeks. after an independent safety review, stage iii will be started wherein additional participants will be randomized in 2:1 to receive daily oral doses of 10 mg rg7314 or placebo for 12 weeks. during stage iii, safety will be reviewed by independent safety review twice and if no safety signal is observed, then additional participants will be randomized in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day rg7314 orally or placebo for 12 weeks in stage iv.


Eligibility criteria:
inclusion criteria: * participants meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for asd and tenth revision of the international classification of diseases and related health problems (icd-10) criteria for autism diagnosis * srs-2 (t-score) greater than or equal to (\>/=) 66 * cgi-s \>/=4 (moderately ill) * participants have an intelligence quotient (iq) \>/=70 (wechsler abbreviated state of intelligence) * a body mass index (bmi) between 18 to 40 kilograms per square meter (kg/m\^2) inclusive * language, hearing and vision compatible with the study measurements as judged by the investigator * lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the participant's compliance with protocol-specified procedures and study medication dosing, and report on the participant's status via completion of study assessments. any period of absence must be covered by another caregiver. non-cohabitating caregiver(s) must spend sufficient time with the participant so that, in the opinion of the investigator, the caregiver(s) can reliably assess participant's mental status, activities and behavior. exclusion criteria: * alcohol and/or substance abuse/dependence during the last 12 months * a significant risk for suicidal behavior, in the opinion of the investigator * systolic blood pressure greater than (\>) 140 or less than (\ 90 or less than (\<) 50 mm hg * resting pulse rate \>90 or \<40 beats per minute * use of prohibited medications or herbal remedies within 2 weeks prior to randomization, or 5 half-lives (whichever is longer) * initiation of a new major change in psychological intervention within 4 weeks prior to randomization. minor changes in ongoing treatment are not considered significant * participation in an investigational drug or device study within 60 days prior to randomization
azithromycin - ivermectin mass drug administration for skin disease

Conditions: Scabies; Yaws; Impetigo

Summary: this is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections. communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2). treatment of yaws: single dose of azithromycin (30mg/kg, max 2g). treatment of scabies: either an oral dose of ivermectin (200μg/kg) or permethrin cream for those with a contraindication to ivermectin (wt\<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart. investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance. primary outcome 1. difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms. secondary outcomes 2. change in the proportion of swab samples from which s. pyogenes is cultured between baseline and follow-up in the two arms 3. the proportion of samples from which a drug-resistant isolate of s.pyogenes is cultured in the two arms


Eligibility criteria:
inclusion criteria: * all community members are able to be included in the study. exclusion criteria: * allergy to any of the components of the allocated drug regimen
propofol versus volatile anesthesia in post operative pain management

Conditions: Varicose Vein; Postoperative Pain

Summary: the study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.

patients undergoing s stripping operation for varicose veins will be randomized to one of two groups. group 1 patients will receive propofol anesthesia. group 2 patients will receive sevoflurane anesthesia. intraoperative measurements including mean-arterial pressure, heart rate, propofol infusion rate, remifentanil infusion rate, and end-tidal sevoflurane concentration will be taken at 15 minute intervals. patients in both groups will receive piritramid as necessary to control pain either intravenously or through patient controlled pump. vas pain score, mean-arterial pressure, heart rate, nausea will be evaluated at 30 minute intervals during the first four postoperative hours. piritramid dosage and vomiting will be recorded through the first postoperative morning. patients will rate pain based on the vas score for the period between leaving the recovery room and the first postoperative morning

Eligibility criteria:
inclusion criteria: * participants will undergo a stripping operation for varicose veins * surgery will be performed by one physician only * written informed consent exclusion criteria: * any contraindications to the proposed interventions * procedures done under regional anesthesia

Keywords: postoperative pain piritramid propofol sevoflurane varicose vein anesthesia
comparison of 24-hours versus 72-hours of octreotide infusion in preventing early rebleed from esophageal varices

Conditions: Esophageal Varices; Liver Cirrhoses; Bleeding Esophageal Varices; Upper Gastrointestinal Bleeding

Summary: this study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.

in cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices. octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. the recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs. this study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.

Eligibility criteria:
inclusion criteria: 1. adult males and females who are 18 years of age or older. 2. evidence or suspicion of upper gastrointestinal bleed (gib) 3. patient with known or suspected cirrhosis 4. upper gib secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (ebl) at presentation 5. willing and able to provide informed consent for study, or have a legally authorized representative (lar) provide consent if the patient is unable to do so exclusion criteria: 1. known upper gastrointestinal malignancy 2. bleeding from gastric varices, with or without esophageal varices 3. use of any other endoscopic method to stop gi bleeding beyond endoscopic band ligation 4. variceal bleeding in the last 90 days 5. history of transjugular, intrahepatic, portosystemic shunt (tips) or vascular decompression surgery 6. pregnant females 7. incarcerated individuals 8. myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks 9. non-cirrhotic portal hypertension causing esophageal varices 10. known or suspected allergy to octreotide
mycophenolate mofetil in gastrointestinal henoch-schonlein purpura

Conditions: Henoch-Schönlein Purpura; Gastrointestinal Injury; Mycophenolate Mofetil

Summary: henoch schönlein purpura (hsp) is the most common type of vasculitis in children, with an incidence of \~10/100,000, whereas \>90% of the patients develop symptoms at \<10 years of age. although hsp is generally a self-limiting disease, it may also lead to severe complications, such as intestinal intussusception, infarction and perforation, as well as end-stage renal disease. the management of hsp includes symptomatic treatment and immunosuppressive therapy in certain patients. previous retrospective studies have reported that most patients with gastrointestinal (gi) symptoms may benefit from early usage of glucocorticoid, whereas there are still a part of hsp patients with gi did not achieved remission after administering of steroid. therefore, the aim of the present study was to investigate the clinical features of refractory gi hsp and the clinical outcome of mycophenolate mofetil in these patients.

the aim of the present study was to investigate the clinical features of refractory gi hsp and the clinical outcome of mycophenolate mofetil in these patients.

Eligibility criteria:
inclusion criteria: 1. ages range from 3 to 18 years old; 2. patients who meet the diagnostic criteria for hsp and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination; 3. refractory gastrointestinal type hsp: treated with intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid 4. parents or guardians agree to treatment and sign a written informed consent form. exclusion criteria: 1. patients who are allergic to mmf; 2. patients with severe diseases: such as systemic malignancies, heart failure, liver and renal failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery; 3. patients with other digestive system diseases; 4. those who have previously used mmf clinical trials; 5. other situations the researcher thought inappropriate to participate in the study.

Keywords: allergic purpura complications, renal involvement gastrointestinal involvement mycophenolate mofetil
effectiveness of conservative interventions in the treatment of trigger finger

Conditions: Trigger Finger; Stenosing Tenosynovitis

Summary: there is no study in the literature comparing the effectiveness of eswt and splint therapy, which are the most commonly used approaches in the treatment of trigger finger (tf). the aim in this study is to investigate the effectiveness of eswt and splint therapy used in the treatment of tf.

volunteer patients who were clinically diagnosed with trigger finger by consulting a doctor at etlik city hospital, hand surgery clinic will be included in the randomized controlled prospective study. patients will be randomly divided into three groups using the 'random sequence generator tab' on random.org, a randomization website, and different treatment programs will be applied. eswt application to a group; splint treatment with eswt to the second group; the third group will receive only splint treatment. eswt application will be performed on a1 puley at 15 hz, 1000 shock wave impuls and 2.0 bar level, for a total of 5 sessions, one week apart. in addition to eswt with the same parameters, a trigger finger splint that immobilizes the mcp joint will be recommended to the eswt and splint treatment group. the patient will be asked to use this splint throughout the day for 8 weeks. the splint group will be offered the same trigger finger splint and will be asked to use it throughout the day for 8 weeks. evaluation and measurements will be repeated for all three groups before treatment, immediately after treatment (8th week) and 4 weeks after the end of treatment (12th week). the number of individuals to participate in the study was calculated as 54 in total, with 18 people in each group (eswt group, eswt+ splint group and splint group), according to the power and sample size analysis based on 80% power and 5% type 1 error rate. power analysis was performed based on pain intensity as the clinical endpoint.

Eligibility criteria:
inclusion criteria: * volunteering * being between the ages of 18-65 * being diagnosed with stage 1 or stage 2 (according to the froimson classification) trigger finger * having the language and cognitive skills to answer the questionnaires used in the evaluation exclusion criteria: * being pregnant * having an inflammatory disorder * having had surgery on the hand/wrist * having a neurological disease * nsaids, painkillers, etc. being on medication * de quervain's tenosynovitis, carpal tunnel syndrome
slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.

Conditions: Heart Failure

Summary: slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria: * peripheral or sacral edema * jugular venous distension or venous central pressure \> 10 mmhg * hepatomegaly or ascites * pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure \> 20 mmhg. * high pro-bnp * randomization during first 24 hours * serum creatinine levels \< 3mg/dl, and k \< 6 mmol/l * the patient should be able to communicate with research staff and meet with study procedures. * the patient will signed informed consent. exclusion criteria: * diagnosis of severe aortic stenosis or severe obstruction to the lvot, tamponade, cardiac hypertrophic or restrictive cardiomyopathy. * impossibility of venous catheterization * acute coronary syndrome * creatinine greater than 3.0 or k greater than 6 mmol/l. * systolic blood pressure less than or equal to 100 mmhg * hematocrit greater than 45% * prior administration of iv vasoactive drugs in the emergency room (er) * clinical instability requiring pressors during hospitalization * sepsis * on or requires renal dialysis.
pralatrexate combined with chidamide bridging allogeneic hsct for refractory/relapsed peripheral t-cell lymphoma

Conditions: Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma

Summary: this is a multicenter, prospective study of pralatrexate combined with chidamide bridging allogeneic hematopoietic stem cell transplantation for refractory/relapsed peripheral t-cell lymphoma


Eligibility criteria:
inclusion criteria: * patients fully understand the study, voluntarily participate in and sign on the informed consent; * diagnosed by histopathology peripheral t-cell lymphoma; * ecog ps score 0 or 1; * relapsed or refractory peripheral t cell lymphoma； * according to the 2014 version of the lugano criteria for lymphoma, there must be at least one ct/mri measurable lesion (measurable lymph node diameter\>1.5cm; measurable extranodal lesion diameter\>1.0cm)； * provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory; * expected survival at least 12 weeks； * agreed to receive treatment with pralatrexate exclusion criteria: * nk/t-cell lymphoma; * achieving cr or pr after induction chemotherapies without relapse; * dysfunction of vital organs; * serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (hiv) antibodies; or other acquired or congenital immunodeficiency diseases; or have a history of organ transplantation; * unwilling to accept allogeneic hematopoietic stem cell transplantation; * undergoing other clinical studies within a month; * without donor for transplantation; * allergies to similar drugs and excipients of the research drug

Keywords: allogeneic hematopoietic stem cell transplantation pralatrexate remission status before transplantation